Associate Staff Quality Engineer

3 weeks ago

San Jose, United States HonorVet Technologies Full time

Title: Associate Staff Quality Engineer - Software DevelopmentLocation: 130 Baytech Drive San Jose CA 95134Duration: 9+ Month Hybrid work schedule is a possibility after 90 days. Job Description Ensures compliance to global and local Product Development Process procedures, through proper development and testing of product software. Ensures compliant transfer of product software to manufacturing according to established procedures to meet all quality requirements. Provides guidance to R&D teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Primary Duties: Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed. Facilitate and participate in product software design reviews, develop quality engineering deliverables, and assure Design History File (DHF) is updated, as necessary. Leads risk management for R&D, including updating risk files based on customer complaint feedback, assessing risk of proposed changes, and performing risk analysis for R&D projects. Serve as primary contact for assigned R&D projects and provide coaching / mentoring to project managers and/or product software development team regarding the product development process, design control, risk assessment, etc. Review and provide feedback on design documentation to support the product development process. Participate in technical or specialty design review(s) for product development and participate as QA representative in the design change management process for product development. Assists in the development, review, and execution of quality management system areas (e.g. change control, document control, risk analysis, design control, verification and validation, etc.). Develop and/or edit standard operating procedures. Contribute to maintain compliance to quality systems and programs in the areas of change management, design control, product verification and validation, initiating CAPAs for relevant design issues, etc, to ensure compliance with FDA and regulatory requirements. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits. Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Supports implementation of corrective actions and preventive measures. Knowledge, Experience & Skills: Bachelor's degree in science related field - e.g., computer science, engineering, biology, etc Requires a minimum of eight (8) years' experience in a related industry regulated by FDA. Requires demonstrated competence in software development processes, good practices, and demonstrates ability to appropriately select and apply quality engineering tools and techniques. Experience applying risk management using ISO 14971 Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.). Requires effective written and oral communication skills to interact across all levels of the organization. Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.). One or more of the following certifications is preferred for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt. Additional Job Information:This position is responsible to assist in the development of quality programs to facilitate continual improvement actions. Also responsible for assuring product quality and reliability during all phases of product life cycle.Domestic Travel Possibly 5% of the timeMust be able to Lift 5-10lbs.Excellent Personal Hygiene Activity Percent of Time (if applicable)Bending - n/aWalking 25% of TimeStanding - 25% of TimeSitting - 50% of TimeTyping - 40% of Time

  • Associate Staff Quality Engineer

    2 weeks ago

    San Jose, United States Infojini Full time

    •Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed. Facilitate and participate in product software design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary. •Leads risk management for R&D, including updating...

  • Associate Staff Quality Engineer

    1 week ago

    San Jose, United States Infojini Full time

    •Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed. Facilitate and participate in product software design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary. •Leads risk management for R&D, including updating...

  • Staff Quality Engineer

    4 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client:Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.Job Location: (Hybrid) Open to San Jose or San Carlos locationsA Day In The Life Of Our Staff DQA Software Engineer:Provide hands-on...

  • Staff Quality Engineer

    4 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client:Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.Job Location: (Hybrid) Open to San Jose or San Carlos locationsA Day In The Life Of Our Staff DQA Software Engineer:Provide hands-on...

  • Staff Quality Engineer

    4 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client:Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.Job Location: (Hybrid) Open to San Jose or San Carlos locationsA Day In The Life Of Our Staff DQA Software Engineer:Provide hands-on...

  • Staff Quality Engineer

    2 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client: Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Job Location: (Hybrid) Open to San Jose or San Carlos locations A Day In The Life Of Our Staff NPD Quality Engineer – ME/EE: Provide...

  • Staff Quality Engineer

    2 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client:Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.Job Location: (Hybrid) Open to San Jose or San Carlos locationsA Day In The Life Of Our Staff NPD Quality Engineer - ME/EE:Provide hands-on...

  • Staff Quality Engineer

    3 weeks ago

    San Jose, United States HealthCare Recruiters International Full time

    Client: Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Job Location: (Hybrid) Open to San Jose or San Carlos locations A Day In The Life Of Our Staff NPD Quality Engineer ME/EE: Provide...

  • Process Quality Engineer

    2 days ago

    San Jose, United States Nutanix Full time

    Quality AssuranceSan Jose,CaliforniaReq.Num.: 26576 Are you a highly motivated and detail-oriented process quality engineer? If so, join our team at Nutanix and be a part of a dynamic company that values ownership, customer obsession, long-term thinking and team work. Supply Chain Operations at Nutanix As a Process Quality Engineer at Nutanix in the Supply...

  • Supplier Quality Engineer

    2 days ago

    San Jose, United States Insight Global Full time

    EKK is looking for a supplier quality engineer to join the team in San Antonio TX. Looking for a long term employee who is eager to learn and grow in the company and eventually transition into management. This position is responsible for strategic quality systems, investigating, analyzing and correcting problems in quality, production and control at a...

  • Quality Engineer

    4 weeks ago

    San Jose, United States Analog Group Inc Full time

    Are you a talented communicator with a passion for quality related topics? Do you like to solve a variety of problems with and for your customers? Then this is the right challenge for you: as a Supplier Quality Engineer you will work with Process and Manufacturing Engineering teams to define process parameters and criteria to ensure supplier process...

  • Quality Engineer

    4 days ago

    San Jose, United States Vantedge Medical Full time

    Quality Engineer Full-time / Permanent Salaried $73K - $120K About Us: Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic...

  • Quality Engineer

    2 days ago

    San Diego, United States Cannon Quality Group Full time

    Job DescriptionJob DescriptionPURPOSE OF JOB:  2nd-level engineering role at CQG. Primarily responsible for client facing engineering solution development and implementation, and to support day-to-day activities surrounding the operation of the client(s) quality system, supplier QA, design assurance and manufacturing QA throughout the product life cycle....

  • Quality Engineer

    4 days ago

    San Jose, United States VANTEDGE Full time

    Quality Engineer Full-time / Permanent Salaried $73K - $120KAbout Us: Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic...

  • Quality Engineer

    2 weeks ago

    San Jose, United States Vantedge Medical Full time

    Quality Engineer Full-time / Permanent Salaried $73K - $120K About Us: Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic...

  • Quality Engineer

    1 day ago

    San Jose, United States VANTEDGE Full time

    Quality Engineer Full-time / Permanent Salaried $73K - $120KAbout Us: Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic...

  • Quality Engineer

    2 weeks ago

    San Jose, United States Vander-Bend Manufacturing, Inc Full time

    Job DescriptionJob DescriptionQuality EngineerFull-time / Permanent Salaried$73K - $120KAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical...

  • Quality Engineer

    1 week ago

    San Jose, United States VANTEDGE Full time

    Quality EngineerFull-time / Permanent Salaried$73K - $120KAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted...

  • Quality Engineer

    2 weeks ago

    San Jose, United States Vantedge Medical Full time

    Quality EngineerFull-time / Permanent Salaried$73K - $120KAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted...

  • Quality Engineer

    2 weeks ago

    San Jose, United States Vantedge Medical Full time

    Quality EngineerFull-time / Permanent Salaried$73K - $120KAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted...